NCT01983228: ACTION

A Proactive Walking Trial to Reduce Pain in Black Veterans

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing Intervention Condition in Musculoskeletal Pain in 500 participants. Completed in 27 February 2020.

Timeline

1 July 2016

Primary endpoint
27 February 2020

27 February 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	500
Start date	1 July 2016
Primary completion	27 February 2020
Estimated completion	27 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Intervention Condition

Conditions studied

• Musculoskeletal Pain — all drugs for Musculoskeletal Pain →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 90, any sex, with Musculoskeletal Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months Primary · Assessed at baseline and 6 months

30% improvement on the Roland Morris Disability Questionnaire \[RMDQ\]) from baseline over the 6-month follow-up period. Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability.

Group	Value	95% CI
Arm 1: Usual Care	38
Arm 2: Intervention Group	46

Change in Brief Pain Intensity Scale at 6 Months Secondary · Baseline and 6 months

Pain intensity assessed by change in Brief Pain Intensity Scale at 6 months. Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.

Group	Value	95% CI
Arm 1: Usual Care	-0.24	± 0.14
Arm 2: Intervention Group	-0.45	± 0.15

Change in Generalized Anxiety Disorder at 6 Months Secondary · Baseline and 6 months

Change in Generalized Anxiety Disorder assessed by 7-item Generalized Anxiety Disorder scale (GAD-7) Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.

Group	Value	95% CI
Arm 1: Usual Care	-0.43	± 0.41
Arm 2: Intervention Group	-0.95	± 0.43

Change in Depression at 6 Months Secondary · Baseline and 6 months

Change in Depression at 6 months assessed by 8-item Patient Health Questionnaire (PHQ-8). Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.

Group	Value	95% CI
Arm 1: Usual Care	-0.96	± 0.38
Arm 2: Intervention Group	-1.56	± 0.40

Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months Secondary · 6 months

Single item measure of patient global impression of change. The investigators will assess this outcome at 6 months. Min=1, max=7, higher scores indicate worse outcome.

Group	Value	95% CI
Arm 1: Usual Care	3.87	± 0.14
Arm 2: Intervention Group	4.26	± 0.13

Mean Change in Average Daily Total Steps at 6 Months Secondary · baseline and 6 months

Pedometer data recorded over past 7 days on patient logs The investigators will assess mean change in this outcome from baseline to 6 months.

Group	Value	95% CI
Arm 1: Usual Care	397.21	± 220.03
Arm 2: Intervention Group	591.11	± 243.02

30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months Secondary · Baseline and 3 months

30% improvement on the Roland Morris Disability Questionnaire \[RMDQ\]) from baseline over the 3-month follow-up period. Minimum = 0 Maximum = 11 Higher scores indicate greater disability The investigators will assess change in this outcome from baseline to 3 months.

Group	Value	95% CI
Arm 1: Usual Care	34
Arm 2: Intervention Group	40

Change in Brief Pain Intensity Scale at 3 Months Secondary · Baseline and 3 months

Pain intensity assessed by Brief Pain Intensity Scale Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.

Group	Value	95% CI
Arm 1: Usual Care	0.02	± 0.14
Arm 2: Intervention Group	-0.58	± 0.15

Change in Generalized Anxiety Disorder, at 3 Months Secondary · Baseline and 3 months

Change in Generalized Anxiety Disorder (GAD-7). Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.

Group	Value	95% CI
Arm 1: Usual Care	-0.75	± 0.42
Arm 2: Intervention Group	-0.39	± 0.44

Change in Depression Using 3 Month Secondary · Baseline and 3 months

Change in Depression at 3 months using the 8-item Patient Health Questionnaire (PHQ-8) Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.

Group	Value	95% CI
Arm 1: Usual Care	-1.27	± 0.42
Arm 2: Intervention Group	-0.79	± 0.43

Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months Secondary · 3 months

Single item measure of patient global impression of change. The investigators will assess this outcome using the 3-month assessment. Min=1, max=7, higher scores indicate worse outcome

Group	Value	95% CI
Arm 1: Usual Care	4.51	± 0.13
Arm 2: Intervention Group	3.79	± 0.13

Mean Change in Average Daily Total Steps, at 3 Months Secondary · 3 months

Pedometer data recorded over past 7 days on patient logs. The investigators will assess mean change in this outcome from baseline to 3 months.

Group	Value	95% CI
Arm 1: Usual Care	92.97	± 207.63
Arm 2: Intervention Group	633.75	± 219.56

Sponsor's own description

The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans.
   Bhimani RH, Cross LJ, Taylor BC, Meis LA, et al · · 2017 · cited 16× · PMID 28086853 · DOI 10.1186/s12891-016-1363-6
2. Taking ACTION to Reduce Pain: a Randomized Clinical Trial of a Walking-Focused, Proactive Coaching Intervention for Black Patients with Chronic Musculoskeletal Pain.
   Burgess DJ, Hagel Campbell E, Hammett P, Allen KD, et al · · 2022 · cited 15× · PMID 35132545 · DOI 10.1007/s11606-021-07376-2
3. The Association Between Racialized Discrimination in Health Care and Pain Among Black Patients With Mental Health Diagnoses.
   Hammett PJ, Eliacin J, Saenger M, Allen KD, et al · · 2024 · cited 6× · PMID 37591480 · DOI 10.1016/j.jpain.2023.08.004